Back to resultsSafety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
Primary Purpose
Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
solithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring NASH, Liver disease
Eligibility Criteria
Inclusion Criteria:
- Histologic evidence of NASH based on liver biopsy obtained within 180 days
- NAS> or = 5
- Able to swallow capsules intact
Exclusion Criteria:
- Symptoms of acute liver disease
- Cirrhosis on liver biopsy
- Positive HIV or Hepatitis tests
- Primary Biliary Cirrhosis
- Poorly controlled diabetes with HgA1C >8.5%
- ALT >4-fold upper limit of normal
- QTcF >450 msec
- CrCl <40 mL/min
Sites / Locations
- Case Western University Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solithromycin
Arm Description
Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks
Outcomes
Primary Outcome Measures
To evaluate effects on hepatic histology in patients with NASH
Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
Secondary Outcome Measures
Changes in Steatosis on liver biopsy
Graded from 0 to 3
Changes in hepatocellular ballooning score on liver biopsy
Graded from 0 to 2
Changes in inflammation on liver biopsy
Graded from 0 to 3
Full Information
NCT ID
NCT02510599
First Posted
July 1, 2015
Last Updated
March 20, 2017
Sponsor
Melinta Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02510599
Brief Title
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
Official Title
An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
January 27, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melinta Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.
Detailed Description
Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis
Keywords
NASH, Liver disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solithromycin
Arm Type
Experimental
Arm Description
Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks
Intervention Type
Drug
Intervention Name(s)
solithromycin
Other Intervention Name(s)
CEM-101
Primary Outcome Measure Information:
Title
To evaluate effects on hepatic histology in patients with NASH
Description
Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Changes in Steatosis on liver biopsy
Description
Graded from 0 to 3
Time Frame
13 weeks
Title
Changes in hepatocellular ballooning score on liver biopsy
Description
Graded from 0 to 2
Time Frame
13 weeks
Title
Changes in inflammation on liver biopsy
Description
Graded from 0 to 3
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic evidence of NASH based on liver biopsy obtained within 180 days
NAS> or = 5
Able to swallow capsules intact
Exclusion Criteria:
Symptoms of acute liver disease
Cirrhosis on liver biopsy
Positive HIV or Hepatitis tests
Primary Biliary Cirrhosis
Poorly controlled diabetes with HgA1C >8.5%
ALT >4-fold upper limit of normal
QTcF >450 msec
CrCl <40 mL/min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Dobbins, MD, PhD
Organizational Affiliation
Melinta Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Case Western University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
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